Registration Dossier
Registration Dossier
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EC number: 216-676-7 | CAS number: 1638-86-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-11-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 92/69, L383A, B5, 1992-12-29
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diethyl phenylphosphonite
- EC Number:
- 216-676-7
- EC Name:
- Diethyl phenylphosphonite
- Cas Number:
- 1638-86-4
- Molecular formula:
- C10H15O2P
- IUPAC Name:
- diethyl phenylphosphonite
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Diethoxyphenlyphosphin- DEOPP
- Physical state: liquid, colourless
- Analytical purity: 98.4 g/100g (GC)
- Lot/batch No.: 96-1008-9-HL
- Date of manufacturing: 1996-07-11
- Storage condition of test material: room temperature, exclusion of moisture, light and oxygen (store under nitrogen)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: females 3.06 kg, males 2.66 kg
- Housing: singel housing in stainless steel wire mesh cages with grating, floor area 3000 cm2
- Diet: standardizes laborators diet (about 130 g/animal/day), ad libitum
- Water: ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied:0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: scoring table according to OECD guideline 405 (1987-02-24) and EEC Directive 92/69, L 383A,B.5 (1992-12-29)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h / 48 h / 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h / 48 h / 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h / 48 h / 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- within 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h / 48 h / 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The average score (24 to 72 hours) for irritation was calculated to be 0 for corneal opacity, iris and chemosis and 0.3 for conjunctivae redness. The findings were reversible in all animals within 48 hours after application.
Any other information on results incl. tables
Irritant/corrosive response data for each animal at each observation time
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
2/2/2 |
2/1/1 |
24 h |
0/0/0 |
0/0/0 |
1/1/1 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
Mean 24h, 48h, 72h |
0/0/0 |
0/0/0 |
0.3/0.3/0.3 |
0/0/0 |
Maximum mean score |
0 |
0 |
0.3 |
0 |
Reversibility*) |
- |
- |
c. |
c. |
Average time for reversion |
- |
- |
48 h |
24 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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